Hypertension (HTN)NCT07670910
University of Georgia Mind Your Heart Pilot Study
A study testing Mind Your Heart and DASH Diet Education in people with Hypertension (HTN) and Obesity & Overweight, run by University of Georgia at 1 site in United States.
Trial summary
The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are: 1. Does participation in a 6-week nutrition education program improve dietary behaviors? 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension (HTN), Obesity & Overweight
- What is being tested?
- Mind Your Heart and DASH Diet Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2022to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years and older
- Current University of Georgia (UGA) employees
- Able to provide informed consent
- Willing to complete online nutrition education modules over a 6-week period
- Willing to attend in-person study visits for baseline and follow-up assessments
- Willing to provide blood samples, blood pressure measurements, and complete eye exams
- Willing to complete online and mobile-based questionnaires
- Access to an internet-enabled device and a mobile phone for surveys and program
Who cannot join
- Unable to complete study procedures, including online modules or in-person visits
- Medical or other conditions that would preclude safe participation in study procedures (e.g., blood draw)
- Lack of access to required technology (internet or mobile phone) for participation
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are:
- Does participation in a 6-week nutrition education program improve dietary behaviors?
- Does participation in the program improve health measures such as blood lipids, blood pressure, and eye nutrient levels?
Read more
Participants will:
- Visit the Institute of Gerontology at the beginning and end of the 6-week study for:
- Blood draws to measure blood lipids (e.g., cholesterol)
- Blood pressure measurement
- Eye exams to assess nutrient levels
- Completion of questionnaires about dietary habits
- Complete online questionnaires before and after the study period
- Participate in the Mind Your Heart program by reviewing 6 online modules over 6 weeks (approximately 20-30 minutes per module)
Read the detailed description
This study examines the efficacy of a 6-week, web-based nutrition education intervention (Mind Your Heart) on dietary behaviors and cardiometabolic health outcomes. The intervention is delivered via the University of Georgia e-Learning Commons (eLC) platform and incorporates evidence-based nutrition education and behavior change strategies.
Participants (UGA employees ≥18 years) are assigned to one of two virtual delivery approaches for the educational content. The intervention consists of six structured modules (approximately 20-30 minutes each), completed over a 6-week period.
Repeated measures are collected to assess behavioral and physiological change. Dietary behaviors and health habits are evaluated using validated self-report instruments administered via Qualtrics at baseline and post-intervention. To capture real-time eating behaviors, participants complete brief mobile-delivered questionnaires three times per week (two weekdays, one weekend day), totaling up to 18 assessments over the intervention period.
Objective health outcomes are assessed at baseline and follow-up laboratory visits and include cardiometabolic and nutritional biomarkers. Measures include venous blood sampling for lipid profiles, resting blood pressure, anthropometrics (height, weight, body composition), and ocular biomarkers (e.g., macular pigment optical density) as an index of nutrient status.
Dietary intake tracking is supported using a third-party application (MyFitnessPal), enabling complementary assessment of dietary patterns. Data are linked using unique study identifiers to ensure confidentiality. Integrated analyses will evaluate changes over time in behavioral and physiological outcomes and examine associations between intervention engagement, dietary behavior, and health indicators.
- Conditions
- Hypertension (HTN), Obesity & Overweight
- Being tested
- Mind Your Heart, DASH Diet Education
- Keywords
- Mindful eating, DASH diet, eHealth
- Medical subject headings
- Hypertension, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind Your HeartBehavioural
The Mind Your Heart intervention is a 6-week web-based behavioral program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules integrating evidence-based DASH diet education with mindful eating training. Content focuses on awareness of hunger and satiety cues, sensory attention to food, and self-regulation of eating behaviors. Participants also complete dietary self-monitoring and ecological momentary assessment activities to support behavior change and reinforce program content.
DASH Diet EducationBehavioural
The DASH Diet Education intervention is a 6-week web-based nutrition education program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules focused on evidence-based DASH dietary recommendations and heart-healthy eating behaviors. Content includes dietary quality improvement, meal planning, portion control, label reading, and dietary self-monitoring to support behavior change.
| Study group | Role | What they receive |
|---|---|---|
| DASH Diet with Mindful eating | Experimental | Participants in this arm will receive the Mind Your Heart program delivered via the e-Learning Commons (eLC) platform, consisting of six asynchronous modules completed over 6 weeks (20-30 minutes each).In addition to standard nutrition education, this arm includes mindful eating training that emphasizes awareness of hunger and satiety cues, eating pace, emotional triggers, and sensory aspects of food. Content integrates mindfulness-based strategies to improve self-regulation and eating behaviors. Participants will track dietary intake using MyFitnessPal and complete brief, repeated surveys assessing eating behaviors. No additional non-dietary intervention components are provided. Receives: Behavioral: Mind Your Heart |
| DASH Diet education only | Active comparator | Participants in this arm will receive the Mind Your Heart nutrition education program delivered via the e-Learning Commons (eLC) platform. The intervention includes six asynchronous modules completed over 6 weeks (20-30 minutes each). Content emphasizes heart-healthy dietary patterns, including increasing fruit and vegetable intake, reducing saturated fat and added sugars, portion control, meal planning, and mindful eating. Behavior change techniques such as goal setting and self-monitoring are incorporated. Participants will track dietary intake using MyFitnessPal and complete brief surveys assessing eating behaviors throughout the intervention. No additional non-dietary intervention components are provided. Receives: Behavioral: DASH Diet Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in DASH Diet Score
Change in DASH diet adherence from baseline to 6 weeks was measured using the Dietary Approaches to Stop Hypertension (DASH) Diet Accordance Score. Dietary intake data were collected using MyFitnessPal and used to calculate adherence to nine DASH nutrient targets: total fat, saturated fat, protein, cholesterol, fiber, calcium, magnesium, sodium, and potassium. Each nutrient is scored as 0 (poor adherence), 0.5 (fair adherence), or 1 (compliant with the DASH target). Scores for all nine nutrients are summed to generate a total DASH Diet Accordance Score ranging from 0 to 9, with higher scores indicating greater adherence to DASH dietary recommendations and a more heart-healthy dietary pattern.
Measured: Baseline to 6 weeks
Change in Three Factor Eating Questionnaire
Change in eating behaviors from baseline to 6 weeks was measured using the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18), an 18-item self-report instrument assessing three domains of eating behavior. Cognitive Restraint (6 items; mean score range 1-4) reflects the conscious restriction of food intake to control body weight or promote weight loss. Uncontrolled Eating (9 items; mean score range 1-4) reflects a tendency to overeat due to loss of control over food intake and responsiveness to hunger or food cues. Emotional Eating (3 items; mean score range 1-4) reflects the tendency to eat in response to negative emotions such as stress, anxiety, or sadness. Higher scores indicate greater levels of the respective eating behavior.
Measured: 6 weeks
Changes in Mindful Eating Behaviors
Change in mindful eating behaviors from baseline to 6 weeks was measured using the Mindful Eating Behavior Scale (MEBS), a 17-item self-report instrument assessing four domains of mindful eating. Focused Eating (5 items; mean score range 1-4) assesses attention to sensory aspects of food and the eating experience. Hunger and Satiety Cues (5 items; mean score range 1-4) assess awareness of and responsiveness to internal hunger and fullness signals. Eating with Awareness (3 items; mean score range 1-4) assesses conscious awareness of eating behaviors. Eating without Distraction (4 items; mean score range 1-4) assesses the ability to eat without engaging in competing activities or thoughts. Higher scores indicate greater mindful eating within each domain. A total MEBS score is not computed.
Measured: 6 weeks
Changes in Motivation
Change in motivation for regulating eating behaviors from baseline to 6 weeks was measured using the Regulation of Eating Behaviors Scale (REBS), a 24-item self-report measure based on Self-Determination Theory. The REBS assesses six types of motivation: Intrinsic Motivation, Integrated Regulation, Identified Regulation, Introjected Regulation, External Regulation, and Amotivation. Items are rated on a 7-point scale. Autonomous motivation is calculated by summing Intrinsic, Integrated, and Identified Regulation subscales; controlled motivation is calculated by summing Introjected, External Regulation, and Amotivation subscales. Both scores range from 12 to 84, with higher scores indicating stronger motivation in the respective category. A self-determination score is calculated from weighted subscale scores, with higher values indicating greater autonomous motivation to regulate eating behaviors.
Measured: 6 weeks
Secondary outcomes (13)
Change in Blood Pressure
Change in resting systolic and diastolic blood pressure from baseline to 6 weeks was measured during in-person study visits using standardized clinical procedures. Blood pressure was recorded in millimeters of mercury (mmHg). Lower systolic and diastolic values indicate improved blood pressure control.
Measured: Baseline to 6 weeks
Change Body weight
Change in body weight from baseline to 6 weeks was measured using a calibrated digital scale. Weight was recorded in kilograms (kg). Lower values indicate weight loss.
Measured: Baseline to 6 weeks
Change in BMI
Change in body mass index (BMI) from baseline to 6 weeks. BMI was calculated using the CDC Adult BMI Calculator based on measured height (cm) and weight (kg). BMI is reported in kg/m², with lower values indicating reduced body weight relative to height. Lower values indicate reductions in body weight relative to height.
Measured: 6 weeks
Change in Waist Circumference
Change in waist circumference from baseline to 6 weeks measured in centimeters (cm) using a standardized tape measure. Lower values indicate reduced central adiposity.
Measured: 6 weeks
Change in Hip-to-Waist Ratio
Change in waist-to-hip ratio from baseline to 6 weeks. Waist-to-hip ratio was calculated by dividing waist circumference (cm) by hip circumference (cm). Lower values indicate a more favorable body fat distribution and lower cardiometabolic risk.
Measured: 6 weeks
Trait Mindfulness
The Mindful Attention Awareness Scale (MAAS) was administered at baseline and used as a stratification variable for randomization, and was reassessed at 6 weeks to evaluate change in trait mindfulness. The MAAS is a 15-item self-report measure of present-moment attention and awareness. Items are rated on a 6-point scale ranging from 1 (almost always) to 6 (almost never). Total scores range from 15 to 90, with higher scores indicating greater trait mindfulness and present-moment awareness.
Measured: 6 weeks
Change in Ocular Nutrient Status
Change in retinal carotenoid status from baseline to 6 weeks was measured as macular pigment optical density (MPOD) using customized heterochromatic flicker photometry with a Macular Metrics Densitometer (Macular Metrics, Rehoboth, MA, USA). MPOD reflects concentrations of the dietary carotenoids lutein, zeaxanthin, and meso-zeaxanthin in the retina. Participants adjusted the intensity of alternating blue (460 nm) and green (570 nm) light stimuli to minimize perceived flicker, and measurements were obtained at a retinal eccentricity of 30 minutes. MPOD is reported in optical density units, with higher values indicating greater retinal carotenoid status.
Measured: Baseline to 6 weeks
Changes in Perceived Stress
Change in perceived stress from baseline to 6 weeks was measured using the Perceived Stress Scale-10 (PSS-10), a 10-item self-report measure assessing the degree to which individuals perceive situations in their lives as stressful, unpredictable, uncontrollable, and overwhelming. Items are rated on a 5-point scale ranging from 0 (never) to 4 (very often). Total scores are calculated by summing item responses after reverse-scoring positively worded items and range from 0 to 40. Higher scores indicate greater perceived stress.
Measured: 6 weeks
Change in Total Cholesterol
Change in fasting total cholesterol from baseline to 6 weeks was measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). Total cholesterol was reported in milligrams per deciliter (mg/dL). Desirable levels are less than 200 mg/dL, borderline high levels are 200-239 mg/dL, and high levels are 240 mg/dL or greater. Lower values indicate improved lipid status.
Measured: 6 weeks
Change in Triglycerides
Change in fasting triglycerides from baseline to 6 weeks was measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). Triglycerides were reported in milligrams per deciliter (mg/dL). Normal levels are less than 150 mg/dL, borderline high levels are 150-199 mg/dL, high levels are 200-499 mg/dL, and very high levels are 500 mg/dL or greater. Lower values indicate improved lipid status.
Measured: 6 weeks
Low-Density Lipoprotein cholesterol (LDL-C)
Change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline to 6 weeks measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). LDL-C was reported in milligrams per deciliter (mg/dL). Optimal levels are less than 100 mg/dL, near optimal levels are 100-129 mg/dL, borderline high levels are 130-159 mg/dL, high levels are 160-189 mg/dL, and very high levels are 190 mg/dL or greater. Lower values indicate improved cardiovascular risk profile.
Measured: 6 weeks
High-Density Lipoprotein cholesterol (HDL-C)
Change in high-density lipoprotein cholesterol (HDL-C) from baseline to 6 weeks was measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). HDL-C was reported in milligrams per deciliter (mg/dL). Low HDL-C is defined as less than 40 mg/dL for men and less than 50 mg/dL for women. Higher values indicate an improved cardiovascular risk profile
Measured: 6 weeks
Fasting Blood Glucose
Change in fasting blood glucose from baseline to 6 weeks measured from fasting venous blood samples collected by a trained phlebotomist and analyzed using the Piccolo Xpress analyzer (Abaxis, Union City, CA). Glucose was reported in milligrams per deciliter (mg/dL). Normal fasting glucose ranges from 70-99 mg/dL, prediabetes is defined as 100-125 mg/dL, and diabetes is defined as 126 mg/dL or greater. Lower values indicate improved glycemic status.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start20 Jan 2022
- Primary completion15 Apr 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Georgia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Reina, University of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07670910
- Sponsor's protocol ID
- PROJECT00003799
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) to be shared will include baseline and follow-up measures of dietary behaviors, dietary intake (e.g., food tracking data), cardiometabolic biomarkers (e.g., blood lipids), blood pressure, anthropometric measures (e.g., weight, BMI, body fat), and ocular nutrient status. Repeated measures data from mobile-based questionnaires assessing real-time eating behaviors will also be included. Demographic variables (e.g., age, sex) necessary for analysis will be provided. All datasets will be stripped of direct identifiers and coded to protect participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- University of Georgia Mind Your Heart Pilot Study
- ClinicalTrials.gov ID
- NCT07670910
- Acronym / sponsor ID
- PROJECT00003799
- Conditions
- Hypertension (HTN), Obesity & Overweight
- Keywords
- Mindful eating, DASH diet, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of GeorgiaUniversity, hospital or other
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if nutrition education can improve eating habits and health outcomes in adults. The main questions it aims to answer are:
- Does participation in a 6-week nutrition education program improve dietary behaviors?
- Does participation in the program improve health measures such as blood lipids, blood pressure, and eye nutrient levels?
Participants will:
- Visit the Institute of Gerontology at the beginning and end of the 6-week study for:
- Blood draws to measure blood lipids (e.g., cholesterol)
- Blood pressure measurement
- Eye exams to assess nutrient levels
- Completion of questionnaires about dietary habits
- Complete online questionnaires before and after the study period
- Participate in the Mind Your Heart program by reviewing 6 online modules over 6 weeks (approximately 20-30 minutes per module)
Detailed description
This study examines the efficacy of a 6-week, web-based nutrition education intervention (Mind Your Heart) on dietary behaviors and cardiometabolic health outcomes. The intervention is delivered via the University of Georgia e-Learning Commons (eLC) platform and incorporates evidence-based nutrition education and behavior change strategies.
Participants (UGA employees ≥18 years) are assigned to one of two virtual delivery approaches for the educational content. The intervention consists of six structured modules (approximately 20-30 minutes each), completed over a 6-week period.
Repeated measures are collected to assess behavioral and physiological change. Dietary behaviors and health habits are evaluated using validated self-report instruments administered via Qualtrics at baseline and post-intervention. To capture real-time eating behaviors, participants complete brief mobile-delivered questionnaires three times per week (two weekdays, one weekend day), totaling up to 18 assessments over the intervention period.
Objective health outcomes are assessed at baseline and follow-up laboratory visits and include cardiometabolic and nutritional biomarkers. Measures include venous blood sampling for lipid profiles, resting blood pressure, anthropometrics (height, weight, body composition), and ocular biomarkers (e.g., macular pigment optical density) as an index of nutrient status.
Dietary intake tracking is supported using a third-party application (MyFitnessPal), enabling complementary assessment of dietary patterns. Data are linked using unique study identifiers to ensure confidentiality. Integrated analyses will evaluate changes over time in behavioral and physiological outcomes and examine associations between intervention engagement, dietary behavior, and health indicators.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DASH Diet with Mindful eating | Experimental | Behavioral: Mind Your HeartParticipants in this arm will receive the Mind Your Heart program delivered via the e-Learning Commons (eLC) platform, consisting of six asynchronous modules completed over 6 weeks (20-30 minutes each).In addition to standard nutrition education, this arm includes mindful eating training that emphasizes awareness of hunger and satiety cues, eating pace, emotional triggers, and sensory aspects of food. Content integrates mindfulness-based strategies to improve self-regulation and eating behaviors. Participants will track dietary intake using MyFitnessPal and complete brief, repeated surveys assessing eating behaviors. No additional non-dietary intervention components are provided. |
| DASH Diet education only | Active comparator | Behavioral: DASH Diet EducationParticipants in this arm will receive the Mind Your Heart nutrition education program delivered via the e-Learning Commons (eLC) platform. The intervention includes six asynchronous modules completed over 6 weeks (20-30 minutes each). Content emphasizes heart-healthy dietary patterns, including increasing fruit and vegetable intake, reducing saturated fat and added sugars, portion control, meal planning, and mindful eating. Behavior change techniques such as goal setting and self-monitoring are incorporated. Participants will track dietary intake using MyFitnessPal and complete brief surveys assessing eating behaviors throughout the intervention. No additional non-dietary intervention components are provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 years and older
- Current University of Georgia (UGA) employees
- Able to provide informed consent
- Willing to complete online nutrition education modules over a 6-week period
- Willing to attend in-person study visits for baseline and follow-up assessments
Key exclusion criteria (3 listed)
- Unable to complete study procedures, including online modules or in-person visits
- Medical or other conditions that would preclude safe participation in study procedures (e.g., blood draw)
- Lack of access to required technology (internet or mobile phone) for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind Your HeartThe Mind Your Heart intervention is a 6-week web-based behavioral program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules integrating evidence-based DASH diet education with mindful eating training. Content focuses on awareness of hunger and satiety cues, sensory attention to food, and self-regulation of eating behaviors. Participants also complete dietary self-monitoring and ecological momentary assessment activities to support behavior change and reinforce program content. | Behavioural | DASH Diet with Mindful eating |
| DASH Diet EducationThe DASH Diet Education intervention is a 6-week web-based nutrition education program delivered through the e-Learning Commons (eLC) platform. The program consists of six structured modules focused on evidence-based DASH dietary recommendations and heart-healthy eating behaviors. Content includes dietary quality improvement, meal planning, portion control, label reading, and dietary self-monitoring to support behavior change. | Behavioural | DASH Diet education only |
Primary outcome
Change in DASH Diet Score
Time frame: Baseline to 6 weeks
Change in DASH diet adherence from baseline to 6 weeks was measured using the Dietary Approaches to Stop Hypertension (DASH) Diet Accordance Score. Dietary intake data were collected using MyFitnessPal and used to calculate adherence to nine DASH nutrient targets: total fat, saturated fat, protein, cholesterol, fiber, calcium, magnesium, sodium, and potassium. Each nutrient is scored as 0 (poor adherence), 0.5 (fair adherence), or 1 (compliant with the DASH target). Scores for all nine nutrients are summed to generate a total DASH Diet Accordance Score ranging from 0 to 9, with higher scores indicating greater adherence to DASH dietary recommendations and a more heart-healthy dietary pattern.
Change in Three Factor Eating Questionnaire
Time frame: 6 weeks
Change in eating behaviors from baseline to 6 weeks was measured using the Three-Factor Eating Questionnaire-Revised 18 (TFEQ-R18), an 18-item self-report instrument assessing three domains of eating behavior. Cognitive Restraint (6 items; mean score range 1-4) reflects the conscious restriction of food intake to control body weight or promote weight loss. Uncontrolled Eating (9 items; mean score range 1-4) reflects a tendency to overeat due to loss of control over food intake and responsiveness to hunger or food cues. Emotional Eating (3 items; mean score range 1-4) reflects the tendency to eat in response to negative emotions such as stress, anxiety, or sadness. Higher scores indicate greater levels of the respective eating behavior.
Changes in Mindful Eating Behaviors
Time frame: 6 weeks
Change in mindful eating behaviors from baseline to 6 weeks was measured using the Mindful Eating Behavior Scale (MEBS), a 17-item self-report instrument assessing four domains of mindful eating. Focused Eating (5 items; mean score range 1-4) assesses attention to sensory aspects of food and the eating experience. Hunger and Satiety Cues (5 items; mean score range 1-4) assess awareness of and responsiveness to internal hunger and fullness signals. Eating with Awareness (3 items; mean score range 1-4) assesses conscious awareness of eating behaviors. Eating without Distraction (4 items; mean score range 1-4) assesses the ability to eat without engaging in competing activities or thoughts. Higher scores indicate greater mindful eating within each domain. A total MEBS score is not computed.
Changes in Motivation
Time frame: 6 weeks
Change in motivation for regulating eating behaviors from baseline to 6 weeks was measured using the Regulation of Eating Behaviors Scale (REBS), a 24-item self-report measure based on Self-Determination Theory. The REBS assesses six types of motivation: Intrinsic Motivation, Integrated Regulation, Identified Regulation, Introjected Regulation, External Regulation, and Amotivation. Items are rated on a 7-point scale. Autonomous motivation is calculated by summing Intrinsic, Integrated, and Identified Regulation subscales; controlled motivation is calculated by summing Introjected, External Regulation, and Amotivation subscales. Both scores range from 12 to 84, with higher scores indicating stronger motivation in the respective category. A self-determination score is calculated from weighted subscale scores, with higher values indicating greater autonomous motivation to regulate eating behaviors.
13 secondary outcomes
Change in Blood Pressure
Time frame: Baseline to 6 weeks
Change Body weight
Time frame: Baseline to 6 weeks
Change in BMI
Time frame: 6 weeks
Change in Waist Circumference
Time frame: 6 weeks
Change in Hip-to-Waist Ratio
Time frame: 6 weeks
Trait Mindfulness
Time frame: 6 weeks
Change in Ocular Nutrient Status
Time frame: Baseline to 6 weeks
Changes in Perceived Stress
Time frame: 6 weeks
Change in Total Cholesterol
Time frame: 6 weeks
Change in Triglycerides
Time frame: 6 weeks
Low-Density Lipoprotein cholesterol (LDL-C)
Time frame: 6 weeks
High-Density Lipoprotein cholesterol (HDL-C)
Time frame: 6 weeks
Fasting Blood Glucose
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) to be shared will include baseline and follow-up measures of dietary behaviors, dietary intake (e.g., food tracking data), cardiometabolic biomarkers (e.g., blood lipids), blood pressure, anthropometric measures (e.g., weight, BMI, body fat), and ocular nutrient status. Repeated measures data from mobile-based questionnaires assessing real-time eating behaviors will also be included. Demographic variables (e.g., age, sex) necessary for analysis will be provided. All datasets will be stripped of direct identifiers and coded to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind Your Heart and DASH Diet Education in people with Hypertension (HTN) and Obesity & Overweight, run by University of Georgia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DASH Diet Score (time frame: Baseline to 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.